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Observational Study
. 2022 Mar 1;150(5):837-846.
doi: 10.1002/ijc.33845. Epub 2021 Nov 8.

A European, prospective, observational study of enzalutamide in patients with metastatic castration-resistant prostate cancer: PREMISE

Heather Payne  1 , Angus Robinson  2 , Bernard Rappe  3 , Serena Hilman  4 , Ugo De Giorgi  5 , Steven Joniau  6 , Roberto Bordonaro  7 , Stéphane Mallick  8 , Louis-Marie Dourthe  9 , Moisés Mira Flores  10 , Josep Gumà  11 , Benoit Baron  12 , Aurea Duran  13 , Alessandra Pranzo  13 , Alexis Serikoff  14 , David Mott  15 , Mike Herdman  15 , Marco Pavesi  15   16 , Maria De Santis  17   18
Affiliations
Observational Study

A European, prospective, observational study of enzalutamide in patients with metastatic castration-resistant prostate cancer: PREMISE

Heather Payne et al. Int J Cancer. .

Abstract

In randomized clinical trials, the androgen-receptor inhibitor enzalutamide has demonstrated efficacy and safety in metastatic castration-resistant prostate cancer (mCRPC). This study captured efficacy, safety and patient-reported outcomes (PROs) of enzalutamide in mCRPC patients in a real-world European setting. PREMISE (NCT0249574) was a European, long-term, prospective, observational study in mCRPC patients prescribed enzalutamide as part of standard clinical practice. Patients were categorized based on prior docetaxel and/or abiraterone use. The primary endpoint was time to treatment failure (TTF), defined as time from enzalutamide initiation to permanent treatment discontinuation for any reason. Secondary endpoints included prostate-specific antigen (PSA) response, time to PSA progression, time to disease progression and safety. PROs included EuroQol 5-Dimension, 5-Level questionnaire, Functional Assessment of Cancer Therapy-Prostate and Brief Pain Inventory-Short Form. Overall, 1732 men were enrolled. Median TTF with enzalutamide was 12.9 months in the chemotherapy- and abiraterone-naïve cohort (Cohort 1) and 8.4 months in the postchemotherapy and abiraterone-naïve cohort (Cohort 2). Clinical outcomes based on secondary endpoints also varied between cohorts. Cohorts 1 and 2 showed small improvements in health-related quality of life and pain status. The proportions of patients reporting treatment-emergent adverse events (TEAEs) were 51.0% and 62.2% in Cohorts 1 and 2, respectively; enzalutamide-related TEAEs were similar in both cohorts. The most frequent TEAE across cohorts was fatigue. These data from unselected mCRPC patients in European, real-world, clinical-practice settings confirmed the benefits of enzalutamide previously shown in clinical trial outcomes, with safety results consistent with enzalutamide's known safety profile.

Keywords: Europe; enzalutamide; metastatic castration-resistant prostate cancer.

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Conflict of interest statement

Heather Payne has attended and received honoraria for advisory boards and lectures, has received travel funds and has served as a consultant for Astellas, AstraZeneca, Bayer, Boston Scientific, Ferring, Janssen, Novartis and Sanofi Aventis during the conduct of the study. Angus Robinson has served as a study investigator with Astellas during the conduct of this study. Bernard Rappe has served as a study investigator with Astellas during the conduct of this study. Serena Hilman has served as a study investigator with Astellas during the conduct of this study and has received financial support to attend educational events from Bayer and Janssen. Ugo De Giorgi has served as a consultant for Astellas, Bayer, BMS, Ipsen, Janssen, Novartis, Pfizer and Sanofi; has received research funding from AstraZeneca, Roche and Sanofi; and has received travel funds from BMS, Ipsen, Janssen, Pfizer and Roche during the conduct of the study. Steven Joniau has served as study investigator with Astellas during the conduct of our study; has received grants, honoraria and nonfinancial support from Astellas, Bayer, Ferring, Ipsen and Janssen; has received honoraria and nonfinancial support from Sanofi; and has received nonfinancial support from AstraZeneca, MDX Health, Pfizer and Roche during the conduct of the study. Roberto Bordonaro has served as a study investigator with Astellas during the conduct of this study. Stéphane Mallick has served as a study investigator with Astellas during the conduct of this study. Louis‐Marie Dourthe has served as a study investigator with Astellas during the conduct of this study and as an investigator for NSD, Janssen and Ipsen. Moisés Mira Flores has served as a study investigator with Astellas; has received grants and nonfinancial support from Astellas and Janssen; and has received nonfinancial support from Ipsen during the conduct of the study. Josep Gumà has served as a study investigator with Astellas; has received grants from Amgen, Ipsen, Pierre Fabre, Roche, Sanofi and Vifor; and has received personal fees from Sanofi. Benoit Baron was employed by Astellas during the conduct of the study. Aurea Duran and Alessandra Pranzo are employees of Astellas Pharma Europe Ltd. Alexis Serikoff is an employee of Astellas Pharma France. David Mott, Mike Herdman and Marco Pavesi have received grants from Astellas Pharma Europe Ltd. during the conduct of this study. David Mott and Mike Herdman are employed at the Office of Health Economics, a registered charity and an independent research organization that receives funding from a variety of private and public sector sources. Marco Pavesi is employed at the European Foundation for the Study of Chronic Liver Failure, which receives funding from a variety of private and public sector sources. Maria De Santis has served as a study investigator with Astellas; has received honoraria from Amgen, Astellas, AstraZeneca, Basilea, Bayer, BioClin, BMS, Calithera, Clovis, Eisai, Ferring, Incyte, Ipsen, Janssen, MSD, Merck, Novartis, Pfizer, Pierre Fabre Oncology, Roche, Sandoz, Sanofi, Seattle Genetics and Takeda; and has received nonfinancial support from the EAU Prostate Cancer Guidelines Panel, the ESMO Bladder Cancer Practice Guidelines Panel and the S3‐Leitlinie Harnblasenkarzinom panel during the conduct of the study.

Figures

FIGURE 1
FIGURE 1
Kaplan‐Meier estimate of TTF: Cohorts 1 and 2
FIGURE 2
FIGURE 2
Mean EQ‐5D‐5L (A and B), FACT‐P (C‐E) and BPI‐SF (F and G) scores over time in Cohorts 1 and 2
See this image and copyright information in PMC

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